Scientist I, Parenteral Drug Product Development

Biogen • Cambridge, MA

2d • Onsite

About The Position

Biogen is presently looking to fill a Scientist I/II position within its Parenteral Formulation and Drug Product Development group. The candidate will be responsible for formulation and process development activities of parenteral drug product programs to support Biogen’s growing pipeline. Candidate is expected to work collaboratively in a matrix environment with other members of the technical development team. The candidate must be motivated and innovative with exceptional analytical and communication skills.

Requirements

• General knowledge of parenteral drug product development and manufacturing.
• Demonstrated experience with pharmaceutical drug product development, preferably sterile drug product development and parenteral formulations.
• Hands-on experience with oligonucleotide, peptide, antibody, or conjugated therapeutics is preferred
• Understanding of drug product manufacturing process operations including mixing, sterile filtration, aseptic filling, lyophilization, and container closure systems.
• Experience planning and executing laboratory experiments, analyzing data, and drawing scientifically sound conclusions.
• Experience with analytical and characterization techniques used for sterile drug products.
• Experience authoring technical reports, protocols, and other CMC documentation; exposure to regulatory submissions such as IND, IMPD, or NDA is preferred.
• Experience with process validation, PPQ, engineering batches, technology transfer, and authoring technical reports, validation documents, and regulatory submissions.
• Experience in analytical and characterization techniques used for characterization of sterile drug products
• Demonstrated ability to work independently on assigned technical activities, solve scientific problems, and effectively collaborate across multidisciplinary teams.

Nice To Haves

• Experience formulating biologics, including high-concentration protein formulations is a plus.
• Experience supporting technology transfer, engineering batches, process validation, or PPQ activities is highly desirable.
• Experience in developing and analyzing drug delivery systems and targeted conjugate molecules is a plus.
• Knowledge of statistical software, design or experiment programming and general visualization of sophisticated data sets is a plus.

Responsibilities

• Design and execute formulation and process development studies supporting preclinical and clinical drug product development, with opportunities to support commercial development activities.
• Contribute to development of sterile parenteral drug products, including formulation optimization, manufacturing process development, and technology transfer.
• Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.
• Execute studies supporting formulation and process optimization, product and process characterization, and manufacturing robustness.
• Collaborate with drug substance, analytical development, device engineering, manufacturing sciences, quality, regulatory, and external manufacturing organizations to support program objectives.
• Support development and evaluation of primary container closure systems, including vials, prefilled syringes, and other delivery systems.
• Support evaluation of manufacturing equipment, single-use systems and filters for drug product development and manufacturing.
• Prepare and coordinate drug product supply for nonclinical studies.
• Author technical reports, development protocols, and other CMC documentation supporting regulatory submissions.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree